HEXZOLE- chlorhexidine gluconate and ketoconazole shampoo

HexZole by

Drug Labeling and Warnings

HexZole by is a Animal medication manufactured, distributed, or labeled by Nootie LLC, Custom Veterinary Services, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:                           Purpose

Chlorhexidine Gluconate …. 2%. . . .   Antibacterial
Ketoconazole ……………… 1% . ...    Antifungal

PURPOSE

Uses: A medicated shampoo with a broad spectrum of antibacterial and antifungal activity for dogs, cats and horses.

WARNINGS AND PRECAUTIONS

Warning: Consult your veterinarian before use. Ask your veterinarian before use if your animal is using any other medications.

When using this product:

• Use only on dogs, cats and horses
• Use topically only
• Avoid contact with eyes and mucous membranes.
• For Animal Use Only

Keep out of reach of children. In case of contact with eyes or mucous membranes, rinse thoroughly with water. If irritation develops or increases, discontinue use and consult your veterinarian immediately.

DOSAGE & ADMINISTRATION

Directions For Use: Wet coat thoroughly with water. Apply sufficient shampoo over the entire body to create a rich lather. Allow to sit on animal between 5 and 10 minutes. Rinse off completely. Repeat procedure if necessary.

Frequency Of Use: Use once or twice weekly or as directed by your veterinarian.

STORAGE AND HANDLING

Storage: Store at room temperature 59º– 86ºF (15C-30C)

Sold exclusively through licensed veterinarians

Made for and Distributed by LOVET
Delray Beach, Florida
www.LovetPet.com

LOVET

ID# VSHZ16 Rev# 0313  /  VSHZ04 Rev#0813
Made In USA

HDPE
Please Recycle

PRINCIPAL DISPLAY PANEL

LOVET Animal Health Dermatology

Medicated Shampoo
Formulated for Dogs, Cats and Horses

HexZole Shampoo

Chlorhexidine Gluconate 2%
Ketoconazole 1%

Antibacterial
Antifungal

Non-Irritating Fragrance Technology™

16 FL OZ (473 ML)  /  4 FL OZ (118 ML)

INGREDIENTS AND APPEARANCE

HEXZOLE 
chlorhexidine gluconate and ketoconazole shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51437-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20.6 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51437-101-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 51437-101-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2013

Labeler - Nootie LLC (008995795)

Registrant - Custom Veterinary Services, Inc. (619511483)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services, Inc.		619511483	manufacture